Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MICRO CO2 APPARATUS

K-Number: K880967 · 1988-04-28

ApplicantHf Scientific, Inc.
Decision Date1988-04-28
Product CodeCIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MICRO CO2 APPARATUS is the device name listed in this FDA 510(k) record. The listed applicant is Hf Scientific, Inc.. It received FDA 510(k) clearance on 1988-04-28 under 510(k) number K880967. The device is classified under product code CIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO CO2 APPARATUS?

MICRO CO2 APPARATUS is a medical device that received FDA 510(k) clearance on 1988-04-28. The listed applicant is Hf Scientific, Inc.. The 510(k) number is K880967.

When did MICRO CO2 APPARATUS receive FDA 510(k) clearance?

MICRO CO2 APPARATUS received FDA 510(k) clearance on 1988-04-28, under 510(k) number K880967.

Who is the listed applicant for MICRO CO2 APPARATUS?

The FDA 510(k) record lists Hf Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO CO2 APPARATUS?

The FDA product code for MICRO CO2 APPARATUS is CIE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hf Scientific, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K882801RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.K874429HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12K864313CO2 REAGENT SETK864862REF. MEMBRANE FOR ORION 1020 SODIUM/POTASSIUM ANA.

Related Devices (Code: CIE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K904761P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENTInstrumentation Laboratory COK864313CO2 REAGENT SETHf Scientific, Inc.K832071TOTAL CO2 REAGENT SETAmerican Research Products Co.K820091AIRMED SMOKE EVACUATION & FILTERJames L. Geraci & Associates, Inc.K800524SERALYZER REFLECTANCE PHOTOMETER/CALIB.Miles Laboratories, Inc.K771610CARBON DIOXIDE ANALYZERCorning Medical & Scientific

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑